FDA Medical Device Recalls (openFDA)
Medtronic Cardiac Surgery Technologies: Medtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip Anastomotic Device Removal Tool is designed to remove U-Clip Anastomotic Devices.
- Recall number
- Z-0968-2007
- Recalling firm
- Medtronic Cardiac Surgery Technologies
- Product
- Medtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip Anastomotic Device Removal Tool is designed to remove U-Clip Anastomotic Devices.
- Status
- Terminated
- Initiated
- 2007-02-08
- Posted
- 2007-06-27
- Terminated
- 2008-02-24
- Reason
- Six lots of U-Clip Removal Tools, catalog REM1860FW were incorrectly assembled. The nose cone attachment to the body of the removal tool does not contain sufficient adhesive which can cause the nose to separate from the body of the device.
- Root cause
- Other
- Action
- Customers to be notified via a letter on 2/8/07. The letter will explain the situation and requests that the impacted product be returned to Medtronic for disposal. The customer will be requested to complete a "Recall Certificate" acknowledging the receipt of this information.
- Quantity
- 187 (US 155, OUS 32)
- Distribution
- Nationwide and Canada.
- Lot, serial or model codes
- lot numbers: 0610707, 0614409, 0614410, 0614411, 0614412, 0622204
- 510(k) numbers
- ["K031623"]
- PMA numbers
- not on file
- Product code
- FZP
- Firm FEI
- 3003368396
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28